BEUDAMED
    MDR MDR QMS Supplemented

    ITH 1343804 1

    Manufacturer: CARDIO CALM S.R.L.
    Basic UDI-DIs
    0
    Scopes
    4
    Preceding Certs
    1
    Risk Classes
    1
    Characteristics
    0
    Revision
    2.0
    294
    Valid for 294 days
    Expiry: April 21, 2027

    Basic Information

    Number
    ITH 1343804 1
    Type
    MDR QMS
    Legislation
    MDR
    Issue Date
    July 8, 2024
    Expiry Date
    April 21, 2027
    Revision
    2.0
    Manufacturer
    CARDIO CALM S.R.L.

    Certificate Lifecycle

    July 8, 2024 April 21, 2027

    Scopes

    4 scopes covering 1 risk classes

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Group Class IIa

    SOFTWARE

    Quality Procedure Scope

    Device Class IIa

    Quality Procedure Scope

    Device Class IIa

    Preceding Certificates

    ITH 1343804 1 Issued
    Issued: April 22, 2022 Expires: April 21, 2027

    Basic UDI-DIs

    This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.